Nigussie 2008b.
Clinical features and settings |
Presenting signs and symptoms: Acutely febrile patients Previous treatment for malaria: No exclusions based on previous treatment; 220 participants were interviewed regarding previous antimalarial use and 24 of these (11%) reported antimalarial use in the previous month Clinical setting: Health centre outpatient departments Country: Ethiopia (Wondo‐Genet) Malaria endemicity: Not stated Malaria endemic species:P. falciparum and P. vivax |
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Participants |
Sample size: 259 received RDT, although 460 were enrolled in the study Age: All ages eligible. Actual age range 1 to 60 years. Sex: Males and females eligible for the study, actual numbers who received Parascreen not presented Co‐morbidities and pregnancy: No exclusions criteria based on co‐morbidities. No details of the frequency of these conditions in the participant population is presented. Parasite density of microscopy positive cases: Not presented |
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Study design | Enrollment was consecutive and prospective. Two RDTs were tested in the study, these are reported separately in this review | |
Target condition and reference standard(s) |
Target condition: Malaria parasitaemia Reference standard: Microscopy thick and thin blood films Person(s) performing microscopy: Technicians who were members of the research team, and independent readers at a central laboratory Microscopy setting: Health centres and Akilu Lemma Institute of Pathobiology parasitology laboratory Number of high power fields examined before declaring negative: 100 Number of observer or repeats: Two, one at the health centre and one at the central laboratory Resolution of discrepancies between observers: There were no discordant results |
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Index and comparator tests |
Commerical name of RDT: Parascreen Pan/Pf (Zephyr Biomedical, Verna, Goa, India) Parasite(s) designed to detect:P. falciparum or mixed infection, non‐falciparum species only Designated Type: Type 3 Batch numbers: Not stated Transport and storage conditions: Not described Person(s) performing RDT: Two well experienced technicians who were part of the research team RDT setting: Health centres |
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Follow‐up | Not applicable | |
Notes | Source of funding: The Global Fund to fight AIDS, TB and Malaria through the Federal Democratic Republic Ethiopian Ministry of Health | |
Table of Methodological Quality | ||
Item | Authors' judgement | Description |
Representative spectrum? All tests | Unclear | Due to a shortage of test kits, only 259 of the 460 participants enrolled in the study received this RDT test, and it is not clear how these participants were selected |
Acceptable reference standard? All tests | Yes | Two independent readers viewed at least 100 high power fields before declaring a slide negative. One reader was based at a central laboratory and there were no discordant results between readers. |
Partial verification avoided? All tests | Yes | All participants who received the index test also received the reference test |
Differential verification avoided? All tests | Yes | The same reference test was used regardless of the index test results |
Incorporation avoided? All tests | Yes | The index test does not form part of the reference standard |
Reference standard results blinded? All tests | Unclear | Blinding not described |
Index test results blinded? All tests | Unclear | Blinding not described |
Uninterpretable results reported? All tests | Yes | Eight participants were excluded due either to incomplete information on either the Paracheck test or the malaria slide |
Withdrawals explained? All tests | Yes | The number of participants enrolled in the study is clearly stated and corresponds to the number presented in the analysis minus the number reported to have invalid test results or incomplete data |